Craniosynostoses Clinical Trial
Official title:
Clinical Feasibility Study of Preoperative Surgical Planning for Craniosynostosis Procedures
Verified date | February 2024 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a subjective visual assessment of the severity of the cranial malformation and the main goal of this procedure is to reduce the risk of elevated intracranial pressure and to provide a more normal cranial shape and volume. Personalized surgical planning systems to optimize intervention and leverage surgical expertise in the reconstruction of the cranial vault do not exist. Thus, the expertise of the surgeon is paramount for the success of the surgical correction of craniosynostosis. The goal of our project is to evaluate the feasibility and utility of a surgical plan derived from software developed at Children's National, iCSPlan.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 20, 2024 |
Est. primary completion date | March 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: 1. Patients under 18 years of age. 2. Diagnosis of craniosynostosis. 3. Scheduled for open crania vault reconstruction. 4. Patients seen in Children's National Medical Center. Exclusion Criteria: 1. Lack of interest in participating and refusal to consent. 2. Plan for endoscopic craniectomy of synostosis. |
Country | Name | City | State |
---|---|---|---|
United States | Childrens National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Gary F. Rogers, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Porras AR, Paniagua B, Enquobahrie A, Ensel S, Shah H, Keating R, Rogers GF, Linguraru MG. Locally affine diffeomorphic surface registration for planning of metopic craniosynostosis surgery. Med Image Comput Comput Assist Interv. 2017 Sep;10434:479-487. doi: 10.1007/978-3-319-66185-8_54. Epub 2017 Sep 4. — View Citation
Porras AR, Paniagua B, Ensel S, Keating R, Rogers GF, Enquobahrie A, Linguraru MG. Locally Affine Diffeomorphic Surface Registration and Its Application to Surgical Planning of Fronto-Orbital Advancement. IEEE Trans Med Imaging. 2018 Jul;37(7):1690-1700. doi: 10.1109/TMI.2018.2816402. — View Citation
Porras AR, Zukic D, Equobahrie A, Rogers GF, Linguraru MG. Personalized Optimal Planning for the Surgical Correction of Metopic Craniosynostosis. Clin Image Based Proced. 2016;2016:60-67. doi: 10.1007/978-3-319-46472-5_8. Epub 2016 Sep 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the feasibility of a surgical planning software (iCSPlan) for open cranial vault reconstructions assessed by how often will the surgeon use or discard the surgical plan | Preoperative planning for cranial vault reconstruction will be built in patients under 18 years old with craniosynostosis. We will document the number of times the surgical plan is followed by the surgeon. | a week before surgery | |
Secondary | To evaluate the utility of the surgical planning software (iCSPlan) assessed by a 5-point Likert scale questionnaire. | Surgeons will review the iCSPlan. To evaluate the utility of the plan, they will complete a questionnaire ranging from 1-5:
Not at all useful; Slightly useful; Moderately useful; Very useful; Extremely useful. |
A week before surgery | |
Secondary | To evaluate the quality of the surgical strategy and the surgical outcome built by the surgical planning software (iCSPlan) surgeons will complete a 5-point Likert scale questionnaire. | After reviewing the iCSPlan, surgeons will evaluate the quality of the surgical strategy and outcome by completing a questionnaire ranging from 1-5.
1: Very poor 2. Poor 3. Fair 4. Good 5. Excellent |
a week before surgery | |
Secondary | To evaluate the impact of the surgical planning software (iCSplan) assessed by the difference in the length of surgery if the plan is used. | Intra-operative variables such as time of surgery is a quantitative measure that would represent the effect of the use of the iCSPlan. We will compare this value in patients for whom the surgical plan was used and was not used. | The day of surgery (One day) | |
Secondary | To evaluate the intra-operative impact of using a surgical planning software (iCSPlan) assessed by the amount of blood loss, and thus, the amount of transfusion needed. | One of the major concern during an open cranial vault reconstruction is the amount of blood loss. Measuring this variable and the number of blood units transfused will let us evaluate the impact of the iCSPlan. | The day of surgery (One day) | |
Secondary | To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the complications encountered 30-days after the surgery. | Complications such as infection, bleeding, reintervention, brain injury, cranial bone loss, among others, will be recorded in a period of 30 days after the surgery. We will compare the number of complications encountered in patients for whom the surgical plan was used and was not used. | 30 days after surgery. | |
Secondary | To evaluate the postoperative impact of undergoing a cranial vault reconstruction following the surgical planning software (iCSPlan) measured by the length of stay. | We will compare the length of stay in patients for whom the surgical plan was used and was not used. | One month. |
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